Oncology update: Boehringer Ingelheim completes enrollment of GioTag real-world lung cancer study

Boehringer Ingelheim has completed the enrollment for GioTag, a real-world, retrospective study to assess the impact of sequential therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). A total of 204 patients who received tyrosine kinase inhibitors (TKIs) – Gilotrif® (afatinib) in first-line, followed by second-line osimertinib as part of standard clinical practice – were enrolled ahead of schedule to determine total time on treatment. Patient data from this study was comprised from 10 countries and included 132 patients from the United States.  

The study was initiated in December 2017 to determine the time on treatment of Gilotrif as first-line therapy in EGFR mutation positive lung cancer followed by osimertinib for patients with T790M resistance mutation, in a real-world setting. Available data on mutations after treatment with osimertinib is also being collected.

Results from this study, which aims to provide insights into the impact of TKIs and delaying subsequent chemotherapy treatment to help inform treatment approaches for EGFR mutation positive NSCLC, are expected to be shared later this year.

Real-world data is a key part of ongoing research and plays an increasingly important role in building the oncology community’s understanding of cancer medicines and their use in patients outside of a clinical trial environment.

What is Gilotrif?

Gilotrif is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

  • has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s).  Your healthcare provider will perform a test to make sure that Gilotrif is right for you. 
  • has spread to other parts of the body (metastatic), and
  • has not been previously treated for metastatic lung cancer

It is not known if Gilotrif is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.

or

is used to treat people with squamous cell lung cancer that:

  • has spread to other parts of the body, and
  • has been previously treated with chemotherapy that contains platinum.

It is not known if Gilotrif is safe and effective in children.

IMPORTANT SAFETY INFORMATION ABOUT GILOTRIF

Before you take Gilotrif, tell your doctor if you:

  • have kidney or liver problems
  • have lung or breathing problems other than lung cancer
  • have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
  • have heart problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Gilotrif can harm your unborn baby. You should not become pregnant while taking Gilotrif.
    • Women who are able to become pregnant should use effective birth control during treatment with Gilotrif and for at least 2 weeks after your last dose of Gilotrif. Talk to your doctor about birth control methods that may be right for you.
    • Tell your doctor right away if you become pregnant or think you are pregnant while taking Gilotrif.
  • are breastfeeding or plan to breastfeed. It is not known if Gilotrif passes into your breast milk. Do not breastfeed while taking Gilotrif and for 2 weeks after your last dose of Gilotrif.  Talk to your doctor about the best way to feed your baby if you take Gilotrif.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works.

What to avoid while taking Gilotrif

Limit your time in the sun. Gilotrif can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn.  Use sunscreen and wear a hat and clothes that cover your skin while you are taking Gilotrif if you have to be in sunlight.

Gilotrif may cause serious side effects, including:

  • Diarrhea. Diarrhea is common with Gilotrif and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with Gilotrif, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
  • Skin reactions. Gilotrif can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
  • Lung or breathing problems. Gilotrif may cause inflammation of the lung that may lead to death.  Symptoms may be similar to those symptoms from lung cancer.  Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
  • Liver problems.  Gilotrif can cause liver problems that can sometimes lead to death.  Tell your doctor right away if you have any symptoms of a liver problem which may include:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea-colored) urine
    • pain on the upper right side of your stomach area (abdomen)
    • bleeding or bruising more easily than normal
    • feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.

  • Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
    • eye pain, swelling, redness, or tearing
    • blurred vision
    • sensitivity to light
    • other changes in your vision
  • Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
    • new or worsening shortness of breath while at rest or with activity
    • cough
    • tiredness
    • swelling of your ankles, feet, or legs
    • feeling that your heart is pounding or racing (palpitations)
    • sudden weight gain

The most common side effects of Gilotrif include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, itching.

Gilotrif may cause decreased fertility in females and males.  Talk to your doctor if you have concerns about your fertility.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information and Patient Information.

GF CONS ISI 01.12.18

MPR-US-100503